FDA Orange Book
Generic for Mifeprex
Mifeprex contains mifepristone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Mifeprex is mifepristone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mifeprex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Marketed (Rx) | AB | 2 | AB |
NDA 020687, held by DANCO LABORATORIES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mifepristone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GENBIOPRO INC | 091178 | AB (A-rated, therapeutically equivalent) | April 11, 2019 | 200MG |
| EVITA SOLUTIONS LLC | 216616 | AB (A-rated, therapeutically equivalent) | September 30, 2025 | 200MG |
Questions
Is there a generic for Mifeprex?
Yes. The generic name for Mifeprex is mifepristone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Mifeprex?
The active ingredient in Mifeprex is mifepristone, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.